MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING 620RG27 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY

Model Number 620RG

Device Problem Material Separation (1562)

Patient Problem Mitral Regurgitation (1964)

Event Date 12/06/2016

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.

Event Description

Medtronic received information that one year post implant of this mitral annuloplasty ring, the device was explanted and replaced with a mitral bioprosthetic valve due to severe mitral regurgitation and dehiscence of the previous valve repair.A post-operative transesophageal echocardiogram (tee) showed no mitral regurgitation.No further adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: RING 620RG27 DURAN ANCORE ANNULOPLASTY C
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6209836
• MDR Text Key: 63407386
• Report Number: 2025587-2016-02078
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00613994758941
• UDI-Public: 00613994758941
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2019
• Device Model Number: 620RG
• Device Catalogue Number: 620RG27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/03/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR